Randomized controlled study evaluating the effect of a biotherapy treatment (anti-RANKL ligand antibody: Denosumab) on bone and vascular metabolism in osteoporotic chronic kidney disease
Phase 1
- Conditions
- MedDRA version: 19.0Level: LLTClassification code 10009119Term: Chronic renal failureSystem Organ Class: 100000004857Therapeutic area: Not possible to specify
- Registration Number
- EUCTR2016-000431-40-FR
- Lead Sponsor
- Health Ministry
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Patient female of 65 years or older
Chronic kidney disease stage 5 patient, hemodialyzed with extracorporeal treatment for at least 3 months
History of vertebral fracture
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30
Exclusion Criteria
Cinacalcet treatment
Substitutive hormonal treatment
Calcium phosphate balance (PTH, 25(OH) vitamin D3, Calcium, phosphate) outside the KDIGO guidelines
Hypersensibility to active substance or one of excipients of Prolia®
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method